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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, flow directed
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K193466  Swan-Ganz Catheters
EDWARDS LIFESCIENCESS LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 144 144
2020 104 104
2021 97 97
2022 130 130
2023 227 227
2024 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 112 112
Pacing Problem 67 67
Inflation Problem 61 61
Deflation Problem 52 52
Incorrect, Inadequate or Imprecise Result or Readings 50 50
Incorrect Measurement 45 45
Leak/Splash 42 42
Adverse Event Without Identified Device or Use Problem 39 39
Appropriate Term/Code Not Available 30 30
Failure to Capture 27 27
Difficult to Advance 27 27
Material Separation 21 21
Burst Container or Vessel 21 21
Material Split, Cut or Torn 21 21
Break 20 20
Detachment of Device or Device Component 20 20
Physical Resistance/Sticking 17 17
Difficult to Remove 15 15
No Pacing 13 13
Material Puncture/Hole 12 12
Fluid/Blood Leak 12 12
Material Deformation 10 10
Failure to Deflate 9 9
No Device Output 9 9
Defective Device 8 8
Unable to Obtain Readings 8 8
Material Integrity Problem 8 8
Component Missing 7 7
Difficult or Delayed Positioning 7 7
Obstruction of Flow 6 6
Material Twisted/Bent 6 6
Difficult to Insert 6 6
Insufficient Flow or Under Infusion 4 4
Entrapment of Device 4 4
Material Fragmentation 4 4
Inaccurate Information 4 4
Defective Component 4 4
Failure to Advance 4 4
Therapeutic or Diagnostic Output Failure 4 4
Activation, Positioning or Separation Problem 4 4
Use of Device Problem 4 4
Connection Problem 4 4
High Test Results 3 3
Device Displays Incorrect Message 3 3
Product Quality Problem 3 3
Contamination 3 3
Gas/Air Leak 3 3
Patient-Device Incompatibility 3 3
Crack 3 3
Output Problem 3 3
Insufficient Information 2 2
Separation Problem 2 2
Disconnection 2 2
Malposition of Device 2 2
Device Contamination with Chemical or Other Material 2 2
Pacing Inadequately 2 2
Tear, Rip or Hole in Device Packaging 2 2
Capturing Problem 2 2
Difficult to Flush 2 2
Device Dislodged or Dislocated 2 2
Failure to Calibrate 1 1
Structural Problem 1 1
Deformation Due to Compressive Stress 1 1
Shipping Damage or Problem 1 1
Degraded 1 1
Particulates 1 1
Signal Artifact/Noise 1 1
Unintended Deflation 1 1
Retraction Problem 1 1
Increase in Pressure 1 1
Coagulation in Device or Device Ingredient 1 1
Contamination /Decontamination Problem 1 1
Delivered as Unsterile Product 1 1
Activation Failure 1 1
Improper or Incorrect Procedure or Method 1 1
Device Contamination with Body Fluid 1 1
Device Ingredient or Reagent Problem 1 1
Unexpected Therapeutic Results 1 1
Migration or Expulsion of Device 1 1
Failure to Sense 1 1
Unintended Movement 1 1
Inadequacy of Device Shape and/or Size 1 1
Pressure Problem 1 1
Low Test Results 1 1
Complete Blockage 1 1
Pacing Intermittently 1 1
Unclear Information 1 1
Material Protrusion/Extrusion 1 1
Excess Flow or Over-Infusion 1 1
Off-Label Use 1 1
Device Markings/Labelling Problem 1 1
Device Alarm System 1 1
Difficult or Delayed Activation 1 1
Temperature Problem 1 1
Calibration Problem 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 400 400
No Consequences Or Impact To Patient 146 146
No Known Impact Or Consequence To Patient 114 114
Insufficient Information 54 54
Hemorrhage/Bleeding 12 12
Vascular Dissection 11 11
No Patient Involvement 10 10
Arrhythmia 9 9
No Code Available 8 8
No Information 6 6
Great Vessel Perforation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Low Blood Pressure/ Hypotension 6 6
Cardiac Tamponade 6 6
Cardiac Perforation 5 5
Needle Stick/Puncture 4 4
Device Embedded In Tissue or Plaque 4 4
Hypersensitivity/Allergic reaction 4 4
Dyspnea 3 3
Anaphylactic Shock 3 3
Cardiac Arrest 3 3
Chest Pain 3 3
Pain 3 3
High Blood Pressure/ Hypertension 3 3
Foreign Body In Patient 3 3
Bradycardia 3 3
Death 2 2
Hemoptysis 2 2
Complaint, Ill-Defined 2 2
Aortic Valve Stenosis 2 2
Failure of Implant 2 2
Extravasation 2 2
Perforation of Vessels 2 2
Perforation 2 2
Unspecified Vascular Problem 2 2
Rupture 2 2
Atrial Fibrillation 2 2
Unspecified Infection 2 2
Swelling/ Edema 2 2
Low Oxygen Saturation 2 2
Anaphylactoid 2 2
Edema 1 1
Myocardial Infarction 1 1
Tingling 1 1
Ectopic Heartbeat 1 1
Pseudoaneurysm 1 1
Injury 1 1
Blood Loss 1 1
Pneumothorax 1 1
Fever 1 1
Air Embolism 1 1
Thrombus 1 1
Cardiopulmonary Arrest 1 1
Anemia 1 1
Sepsis 1 1
Therapeutic Effects, Unexpected 1 1
Exposure to Body Fluids 1 1
Reaction 1 1
Tissue Damage 1 1
Atrial Flutter 1 1
Pulmonary Embolism 1 1
Septic Shock 1 1
Complete Heart Block 1 1
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Dec-19-2019
2 Edwards Lifesciences, LLC II Apr-12-2023
3 Edwards Lifesciences, LLC I Jan-31-2019
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